RCI-ABBV-35480 QC Bioassay Analyst / Scientist (Cell-Based Potency Assays/Biologics/ELISA/Cell Banking)

Rangam; Irvine (CA); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Rangam is seeking a highly skilled professional in Irvine, CA to perform cGMP cell-based potency assays and data generation for biologics client projects. The role emphasizes timely testing, data integrity, and adherence to quality systems.

Responsibilities include generating technical reports, reviewing raw data, maintaining cell culture and banking, and supporting regulatory inspections while ensuring instrument calibration and SOP updates. Strong GMP experience is essential.

Qualifikationen

• Experience in a GMP regulated environment.
• Experience in bioassays, Chemi-ECL ELISA, PCR and automation preferred.
• Experience with aseptic cell culture and cell banking preferred.
• Proficiency in quality systems.
• Laboratory investigations, change controls, non-conformances.

Aufgaben

• Perform cGMP cell-based potency assays testing in support of the manufacture of client’s biologics products. Responsible for the timely completion of assigned laboratory testing.
• Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies.
• Review and approve raw data and laboratory logbooks/worksheets.
• Perform cell culture and cell banking.
• Manage critical reagents and supplies.
• Write quality systems records including laboratory investigations, change controls, non-conformances.
• Support regulatory inspections where needed.
• Ensure that all lab equipment is used and maintained correctly. Support lab equipment validation and equipment preventive maintenance.
• Generate and update SOPs.
• Adhere to and supports all EHS standards, procedures and policies.
• Understand regulations and business processes required to maintain laboratory data integrity.
• Maintain and comply with laboratory documentation and computerized systems data integrity requirements.

Kenntnisse

GMP experience

Bioassays/ELISA/PCR

Cell culture & banking

Quality systems

Investigations/change controls

Jobbeschreibung

What are the top 3-5 skills, experience or education required for this position:

• Experience in a GMP regulated environment.
• Experience in bioassays, Chemi-ECL ELISA, PCR and automation preferred.
• Experience with aseptic cell culture and cell banking preferred.
• Proficiency in quality systems
• Laboratory investigations, change controls, non-conformances.

Major Responsibilities:

• Perform cGMP cell-based potency assays testing in support of the manufacture of client’s biologics products. Responsible for the timely completion of assigned laboratory testing.
• Generate, compile, and evaluate data for technical reports to support commercial and clinical supplies.
• Review and approve raw data and laboratory logbooks/worksheets.
• Perform cell culture and cell banking.
• Manage critical reagents and supplies.
• Write quality systems records including laboratory investigations, change controls, non-conformances.
• Support regulatory inspections where needed.
• Ensure that all lab equipment is used and maintained correctly. Support lab equipment validation and equipment preventive maintenance.
• Generate and update SOPs.
• Adhere to and supports all EHS standards, procedures and policies.
• Understand regulations and business processes required to maintain laboratory data integrity.
• Maintain and comply with laboratory documentation and computerized systems data integrity requirements.

Regulated Responsibilities (including cGMP and EHS):

Client is a regulated company and the incumbent is expected to be fully compliant with all criteria established by governmental agencies, Ministry of Health, and legislative requirements including, but not limited to:

the FDA, European Community (EC), ISO 13485 - Medical Devices, European Economic Community Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), OSHA, Sarbanes-Oxley, EPA, DOT, EEOC, and ADA.

Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate.